Kornimate/medical-research-clean huggingface dataset:
newborn ventilation in the delivery room: could it be improved with a t-piece resuscitator?

Conditions: Resuscitation

Summary: a multicenter cross-over cluster randomized controlled trial protocol study in newborn infants ≥ 26 weeks gestational age requiring assisted ventilation (positive pressure ventilation \[ppv\]) for resuscitation in the delivery room comparing a t-piece resuscitator device versus resuscitation bag.

design: a multicenter cross-over cluster randomized controlled trial. our hypothesis is based on the assumption that ventilating depressed newborns with a t-piece resuscitator will be more effective than sib by increasing the proportion of resuscitated newborns with heart rate (hr) ≥ 100 beats per minute (bpm) at two minutes of life as a proxy for successful resuscitation. population: newborn infants ≥ 26 weeks gestational age requiring assisted ventilation (ppv) for resuscitation in the delivery room. (need for assisted ventilation at positive pressure: heart rate \[hr\] \< 100 beats per minute \[bpm\], apnea, gasping, cyanosis and/or hypotonia) intervention: ppv will be performed with a t-piece resuscitator (neopuff® group) with positive end expiratory pressure. control: ppv will be performed with a self inflating bag (sib group) with and without peep. both devices will be used with face masks, and a peak inspiratory pressure (pip) of 25 cm h2o will be used to begin ventilation with peep of 0 cm h2o in the subgroup without peep valve, 5 cm h2o in the subgroup with peep valve in the sib group, and 5 cm h2o in the neopuff® group. objective: to compare the effectiveness of both instruments in reaching a heart rate of ≥ 100 bpm in depressed newborns of ≥ 26 weeks' gestational age (ga) after the initiation of positive pressure ventilation (ppv) with face mask. primary outcome: proportion of newborns with hr ≥ 100 bpm at 2 minutes of life. type of comparison: which of the two devices neopuff tm or self inflating bag (np/sib)will be more effective for ventilation of the newborn, by increasing the proportion of resuscitated newborns with heart rate (hr) ≥ 100 beats per minute (bpm) at two minutes of life as a proxy for successful resuscitation.

Eligibility criteria:
inclusion criteria: live-born infants of ≥ 26 weeks' ga with hr \< 100 bpm requiring resuscitation with positive pressure ventilation with mask in the delivery room according to the current aap/aha recommendations exclusion criteria: infants requiring intubation from birth. newborns of \< 26 weeks´ ga. newborns presenting major congenital malformations. multiple births. problems (difficulty or malfunctioning) with the device assigned.

Keywords: bag and mask neopuff resuscitation newborn intubation devices peep
inpatient package to reduce hiv and aids-related death in zambia

Conditions: HIV/AIDS; Transitions of Care; Hospitalization; Tuberculosis; HIV Testing; Cryptococcosis

Summary: early post-discharge mortality is high among hiv-infected zambians admitted to the hospital. likely this is in part due to missed opportunities to identify lethal coinfections and optimize hiv care during admission (and before discharge). in this study the investigators will develop and pilot a new approach to inpatient hiv care that follows international guidelines for management of advanced hiv disease.


Eligibility criteria:
inclusion criteria: * 18+ years old * hiv-positive (by self-report or dct result in uth file) * resident of lusaka * admitted to the hospital exclusion criteria: * too sick to provide informed consent (based on clinician opinion) * likely to be discharged in the next 48 hours (based on clinician opinion)
zoledronic acid in children (1 -17 years) with severe osteogenesis imperfecta

Conditions: Osteogenesis Imperfecta

Summary: this is an extension study to examine the long-term safety and efficacy of zoledronic acid in patients who have completed the core czol446h2202 study.


Eligibility criteria:
inclusion criteria: * have completed the core czol446h2202 study * males or females between 1-17 years of age exclusion criteria: * deformity or abnormality which would prevent spine bone density from being done * any surgical bone-lengthening procedure * any kidney diseases or abnormalities * low calcium or vitamin d levels in the blood other protocol-defined inclusion/exclusion criteria may apply.

Keywords: osteogenesis imperfecta, brittle bone disease, bisphosphonate, children
optimal duration of pre-operative treatment with letrozole and to correlate clinical efficacy with appropriate surrogate markers

Conditions: Breast Cancer

Summary: this study will assess optimal duration of pre-operative treatment with letrozole and to correlate clinical efficacy with appropriate surrogate markers.


Eligibility criteria:
inclusion criteria: 1. female breast cancer patients with primary invasive breast cancer, histologically confirmed by core needle biopsy, whose tumors are estrogen (er) and / or progesterone (pgr) positive (clinical stage \*t2, t3, t4a,b,c, n0, m0) 2. patients after menopause 3. tumor measurable by clinical examination, mammography and ultrasound 4. adequate bone marrow, renal and hepatic function 5. a life expectancy of at least 6 months. exclusion criteria: 1. prior treatment with aromatase inhibitors or antiestrogens. 2. uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, cushing´s syndrome, addison´s disease (treated or untreated), patients with unstable angina, uncontrolled cardiac disease (e.g. class ii or iv new york heart association's functional classification). 3. patients with tumors in both breasts, evidence of inflammatory breast cancer or distant metastasis 4. patients who are eligible for breast conserving surgery. 5. concomitant anti-cancer treatments such as chemotherapy, immunotherapy/biological response modifiers (brm's), endocrine therapy (including steroids), bisphosphonate therapy and radiotherapy. patients who have received hrt will not be excluded, provided that hrt is discontinued at least 2 weeks prior to entry into the study. other protocol defined inclusion/exclusion criteria may apply

Keywords: breast cancer neoadjuvant treatment treatment duration primary hormone receptor positive breast cancer in postmenopausal women
assessment of cardiac autonomic behavior in patients with mood disorders

Conditions: Mood Disorder; Mania; Depression

Summary: the purpose of this study is to characterize the behavior of cardiac patients with mood disorders and its clinical course, interpreting the results from a theoretical framework of chaos theory and complexity theory and systems as well.

mood disorders are strongly associated with changes in cardiovascular function and alterations in hear rate variability (hrv). fluctuation in heart rate occurs over a wide frequency and demonstrates a broad, irregular variability that suggests that the mechanisms involved in cardiovascular regulation interact in a nonlinear manner. over the past decade, there has been an increasing emphasis on applying nonlinear methods of analysis to characterize cardiac function, but the studies on the pathophysiology of mood disorders in general still remain under a linear and reductionist perspective. the scarcity of both brazilian and international studies on the autonomic behavior in mood disorders in general and not only in major depressive disorder, as well as the use of a non-linear reading of the results of this study makes an additional tool of analysis.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of bipolar disorder (bd) or major depressive disorder(mdd) exclusion criteria: * another with criteria for axis i or ii disorders aside from the primary diagnosis of bd or mdd. * past history of stroke, heart attack, or cardiac disease. * drug abuse or dependence in the past six months. * diabetes. * in use of tricyclic antidepressants

Keywords: chaos theory heart rate variability mania bipolar disorder
exercise to restore 24h rhythms in metabolism

Conditions: Diabetes Mellitus, Type 2; Insulin Resistance

Summary: this study will investigate the effect of exercise training on 24h rhythms in substrate metabolism in overweight subjects with impaired glucose tolerance. subjects will perform exercise training for 12 weeks. before and after the exercise period, they will be admitted to research facilities for 45 hours to assess 24h rhythms in substrate metabolism. in a single-arm longitudinal design, subjects will serve as their own control.

recent evidence shows that pre-diabetes is characterized by marked alterations in 24h substrate metabolism, indicating metabolic inflexibility with an inability to fully switch to fat oxidation during the night. whereas exercise has been shown to promote mitochondrial function and insulin sensitivity, it is unknown to if exercise training is able to restore 24h rhythmicity in overall substrate metabolism and muscle metabolism in human subjects with pre-diabetes. in this single-arm longitudinal design, subjects will serve as their own control. subjects will perform high-intensity interval training for 12 weeks (3x times per week) on a cycle ergometer at the research facility. pre and post exercise, subjects will stay in a metabolic chamber and adhere to a relatively normal life-style in order to standardize the main 24h measurement period. as the primary outcome, substrate metabolism will be measured with a ventilated hood system and by indirect calorimetry in the chambers. muscle biopsies from the vastus lateralis and frequent blood samples will also be taken over the course of the 24h. thereby, ex-vivo skeletal muscle mitochondrial function and muscle clock gene expression will serve as the main secondary outcomes.

Eligibility criteria:
inclusion criteria: * caucasian * healthy (as determined by dependent physician) * overweight: bmi 25 - 35 kg/m2 * prediabetic based on one or a combination of the following criteria: * impaired glucose tolerance (igt): plasma glucose values ≥ 7.8 mmol/l and ≤ 11.1 mmol/l 120 minutes after glucose drink consumption during ogtt in screening. * impaired fasting glucose (ifg): fasting plasma glucose ≥ 6.1 mmol/l and ≤ 6.9 mmol/l. * insulin resistance: glucose clearance rate ≤ 360ml/kg/min, as determined using the ogis120 model. * hba1c of 5.7-6.4%. * regular sleeping time (normally 7 - 9h daily) * stable dietary habits: no weight gain or loss \> 3kg in the last three months. exclusion criteria: * use of anticoagulants * previously diagnosed with type 2 diabetes * current alcohol consumption \> 20 grams alcohol/day * extreme early bird or extreme night person (score ≤ 30 or ≥ 70 on meq-sa questionnaire) * heavily varying sleep-wake rhythm * nightshift work during last 3 months * travel across \> 1 time zone in the last 3 months * significant food allergies/intolerance (seriously hampering study meals) * using \> 400mg caffeine daily (more than 4 coffee or energy drink) * smoking

Keywords: circadian rhythm
the effects of resistance exercise and protein supplementation in hemodialysis patients

Conditions: End Stage Renal Disease

Summary: the objective of this study is to determine how protein supplementation, with or without exercise, affects functional capacity, strength, body composition, and physical activity in hemodialysis patients.


Eligibility criteria:
inclusion criteria: * on hemodialysis for more than 3 months, on a thrice weekly hemodialysis program; * adequately dialyzed (kt/v ≥ 1.2). * age ≥ 18 years old. exclusion criteria: * patients unable to perform exercise due to cardiovascular disease, osteoarthritis, etc., as determined by the pi and the primary physician of the subject. * pregnant women. * patients hospitalized within the last month prior to the study.
sternotomy pifb block in open heart surgery

Conditions: Autonomic Nerve Block

Summary: the purpose of this study is to evaluate if the use of a bilateral nerve block with a local anesthetic (ropivacaine), as part of a standard of care pain control regimen (called multimodal analgesia \[mma\]), has a favorable effect on our institutional mma pain regimen. subjects will go through the following study procedures: review of medical history and medications subjects have taken within a month prior to surgery. subjects will be randomly assigned to one of the two study groups (1:1) to receive either, an ultrasound-guided bilateral nerve block (called "pecto-intercostal fascial block \[pifb\]") with ropivacaine or saline 0.9 solution, in addition to our institutional mma regimen. a baseline line pain and nausea scores will be recorded before surgery. the block will be performed right after general anesthesia induction. the details about the surgery will be collected. pain assessments, nausea and vomiting scores will be registered at 12, 24 and 48 hours after surgery as well. lastly, a follow up phone call will be made by the research team to conduct a pain-detect questionnaire at 30, 60 and 90 days after surgery.

study design this is a single-center, prospective, randomized, placebo-controlled, double-blinded trial in patients undergoing open-heart surgery at richard m. ross hospital - the ohio state university medical center. all study procedures will be done in accordance with institutional and orrp-irb guidelines. study participants adult patients undergoing open-heart surgery at richard m. ross hospital - the ohio state university medical center with an american society of anesthesiologists (asa) physical status of i to iv who are scheduled to undergo open-heart surgery at richard m. ross hospital - the ohio state university medical center. sample size eighty-four subjects who give written informed consent to participate in the study and who meet all inclusion and no exclusion criteria will be included in a single treatment group.

Eligibility criteria:
inclusion criteria: * adult male or female patients aged \> 18 * undergoing primary cardiac surgery requiring sternotomy * able to provide a signed written informed consent * able to speak, read, and write in english * american society of anesthesiologists (asa) physical status i-iv exclusion criteria: * any documented cognitive or psychological disorders that, in the opinion of the principal investigator, can interfere with the patients' pain perception * diabetes mellitus with documented neuropathic pain * vulnerable populations: pregnant females, prisoners, breast feeding * contraindication to nerve block: local infections, bleeding disorders, chest wall deformity, allergy to local anesthetic or dexamethasone * previous cardiac surgery * previous history of chronic pain diseases requiring consistent analgesic therapy for at least 1 month prior to surgery * presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study * bmi ≥ 40 kg/m2
a study to evaluate the effect of lansoprazole on infants with gastroesophageal reflux disease.

Conditions: Gastroesophageal Reflux Disease

Summary: the purpose of this study is to understand how quickly lansoprazole, once daily (qd), improves feeding in premature babies or babies less than 28 days of age.

a phase 1, multicenter, pharmacokinetic/pharmacodynamic and safety study in which infants will be randomized in an open-label fashion to receive 5 days of open-label treatment with lansoprazole pediatric suspension 1 mg/kg/day oral, or lansoprazole pediatric suspension 2 mg/kg/day oral. on dosing days 1 and 5, blood samples will be obtained for drug assay. all subjects will be evaluated for inclusion in the ph monitoring portion of the study and will undergo ph monitoring, provided it is clinically indicated, at the discretion of the investigator. intragastric ph monitoring (up to 24 hours) will be performed at baseline, on dosing day 1 (or day 2) and on dosing day 5 (or day 6). intraesophageal ph may be done in addition to intragastric ph at the discretion of the investigator. subjects will be evaluated for safety, including a follow-up visit on post-dosing day 14.

Eligibility criteria:
inclusion criteria: * hospitalized or outpatient male or female, term or post-term infants beyond the neonatal period (\>28 days) but less than 12 months of age, or a preterm infant with a corrected age of at least 44 weeks but less than 12 months on dosing day 1. * clinically-evident gastroesophageal reflux disease (feeding intolerance, regurgitation, wheezing or stridor with feedings) * at least 7 days post-surgery without anticipated need for surgery during study * no significant laboratory abnormalities exclusion criteria: * unstable, clinically significant disease or abnormality * congenital anomaly of the upper gastrointestinal tract * clinical evidence of acute sepsis * cystic fibrosis * medical condition requiring subject to not be fed by mouth/gastric tube

Keywords: pediatric gerd pediatric gastroesophageal reflux disease lansoprazole
residual renal function preservation in peritoneal dialysis patients

Conditions: Chronic Renal Disease

Summary: aldosterone blockade is useful in preserving residual renal function in patients on pd.the long term efficacy of dual blockade of the raas is better than monotherapy.

residual renal function has been proven to contribute to improved survival and quality of life of dialysis patients. it is now recognized as an important factor in the prognosis of pd.the raas system is involved in the development of renal diseases. angiotensin ii and aldosterone are vital in this process. the beneficial effect of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker on residual renal function has been demonstrated in peritoneal dialysis patients. unfortunately, neither ace inhibition nor angiotensin receptor blocker fully supprsses aldosterone production. now much focus has been placed on aldosterone antagonist.

Eligibility criteria:
inclusion criteria: * patients who having been on pd continuously for one month, urine volume\>600 ml/d, residual renal function\>2ml/min/1.73m2, blood pressure\>120/70mmhg, serum potassium levels\<5.5mmol/l, stable clinical condition. exclusion criteria: * patients with infectious systemic disease, peritonitis during the preceding 1 month, who had taken acei/arbs in the 3 preceding months, spirolactone in the 2 preceding weeks, intolerance to acei/arbs, chf, mi, malignant hypertension and stroke within the preceding 6 months.

Keywords: peritoneal dialysis； residual renal function； raas
intravenous gammaglobulin for sickle cell pain crises

Conditions: Sickle Cell Disease; Pain

Summary: the purpose of this study is to determine whether intravenous immune globulin is safe and effective in the acute treatment of pain crises in sickle cell disease. funding source: food and drug administration (fda), office of orphan products development (oopd)

patients will be randomized to a single dose of ivig versus normal saline placebo during an uncomplicated pain crisis. length of voc and other secondary endpoints will be monitored.

Eligibility criteria:
each subject must fulfill each of the following inclusion/exclusion criteria at screening and continue to fulfill these criteria prior to dosing: inclusion criteria: * documented sickle cell disease (ss or s-β thalassemia genotype) * age 12-65 years for phase 1 (completed), 6-13.99 years for phase 2 (ongoing) * normal stroke risk as assessed by transcranial doppler (tcd). a normal tcd in subjects 16 years of age and younger within the year prior to study drug administration are required * uncomplicated acute vaso-occlusive crisis requiring hospital admission and parenteral narcotic analgesics * if prescribed voxelotor: consistent daily use of voxelotor in the past week and able to continue voxelotor inpatient or no reported use in prior week exclusion criteria: * concomitant acute process, including acute chest syndrome, potential serious infection, or clinically significant bleeding * fever \> 38.5° c and clinical suspicion of infection * serum alanine aminotransferase \>4x upper limit of normal (uln) * serum creatinine ≥1.3 mg/dl (or \> than 95th percentile for age) or \>300 mg/dl protein in spot urinalysis * known condition associated with renal dysfunction including but not limited to diabetes mellitus, uncontrolled hypertension, multiple myeloma, and congestive heart failure * any clinical evidence of prior stroke * prior thromboses or current estrogen use * current estrogen use * hb \ 10 g/dl * known immunoglobulin a (iga) deficiency or known allergy to gamma globulin * pregnancy or breastfeeding * current participation in another investigational drug study * current enrollment in a hypertransfusion program * previous participation in current study less than 3 months ago * current treatment with chronic transfusion * vaccination with a live attenuated virus in the preceding 6 weeks * documented history of illicit (e.g., heroin, cocaine) drug abuse * subject is otherwise not an appropriate study candidate, in the investigator's judgement, such as concern for opioid addiction or comorbid psychiatric diagnoses that may contribute to secondary gain in prolonged use of opioids or hospital stay * greater than 24 hours from time of presentation to the hospital for voc * atrial fibrillation * right to left cardiac shunting due to patent foramen ovale or other anatomic cause * known magnetic resonance imaging/angiography (mri/a) evidence of stroke or clinically significant central nervous system (cns) vasculopathy at any age (imaging done if clinically indicated)

Keywords: sickle cell disease pain immune globulin
subjective comparison of pre-lens tear film stability with daily disposable contact lenses

Conditions: Myopia; Hyperopia; Refractive Error

Summary: the purpose of this study was to compare three ce-marked daily disposable contact lenses for tear film stability as measured by pre-lens non-invasive keratograph break up time (pl nik-but). secondarily, contact lens surface wettability was assessed.

each participant wore 3 brands of contact lenses in a randomized, cross-over fashion, with a washout phase of at least 1 night between brands.

Eligibility criteria:
inclusion criteria: * sign informed consent. * adapted soft contact lens wearer. * willing to wear contact lenses up to 12 hours and attend all study visits. * vision correctable to 0.1 (logmar) or better in each eye at distance with pre-study lenses at visit 1. * contact lens prescription within the power range specified in the protocol. * other protocol-defined inclusion criteria may apply. exclusion criteria: * any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear. * any use of systemic or ocular medications that would contraindicate contact lens wear. * any ocular finding observed during the visit 1 examination that would contraindicate contact lens wear. * monocular (only 1 eye with functional vision) or fit with only 1 lens. * history of herpetic keratitis, ocular surgery, or irregular cornea. * known pregnancy. * unstable tear film with a nik-but value below 13 seconds in either eye without lenses. * participation in any clinical study within 30 days of visit 1. * other protocol-defined exclusion criteria may apply.

Keywords: soft contact lenses daily disposable contact lenses tear film break up time contact lens wettability